Coagulation Disorders Secondary to Two Plasmapheresis Techniques (Double Filtration Plasmapheresis vs. PFS). Descriptive Pilot Study.

NCT ID: NCT06571552

Last Updated: 2024-12-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-17
• Study Completion Date: 2026-06-30

Brief Summary

Therapeutic plasmapheresis causes changes in haemostasis by purifying many of the circulating factors involved. Few reliable data are available on these changes and most studies are limited to coagulation factor assays before and after the session, with little data documenting the kinetics of regeneration of these factors. It is recognized that haemostasis disorders caused by therapeutic apheresis must be corrected in cases of active bleeding. However the methods of correcting these disorders are debatable. Finally, it is unclear when changes in haemostasis associated with coagulation factor deficiency should be corrected. Haemostasis is probably not based solely on the level of blood fibrinogen, but it is most often its threshold that is used to trigger replacement therapy to prevent a supposed risk of haemorrhage. No studies are available on the kinetics of haemostasis disorders and the risk of haemorrhage following a therapeutic plasmapheresis session, according to session type and fibrinogen level at the end of the session. The hypothesis of this research is that the link between fibrinogen level and thrombin generation capacity, post therapeutic plasmapheresis, will enable us to better assess the risk of haemorrhage and propose preventive measures.

Detailed Description

Therapeutic plasmapheresis causes changes in haemostasis by purifying many of the circulating factors involved. Some data are available on changes in circulating haemostasis factors with the Single Plasma Exchange technique and the Double Filtration Plasmapheresis; however, most often these studies are carried out in specific clinical situations where other haemostasis disorders may be present, such as severe renal failure. Furthermore, in these studies, assessment of changes in haemostasis is often limited to coagulation factor assays before and after the session, with little data documenting the kinetics of regeneration of these factors, whose molecular weight and half-life vary widely. To date, there is no clear consensus/recommendation on the management of haemostasis disorders secondary to therapeutic apheresis. The need to correct haemostasis disorders caused by therapeutic apheresis also appears to be consensual in cases of active bleeding.The methods of correcting haemostasis disorders can also be discussed between infusion of coagulation factor and fresh frozen plasma. Finally, apart from these clinical situations, it is not clear when changes in haemostasis associated with coagulation factor deficiency should be corrected. There are no studies available on the kinetics of haemostasis disorders and the risk of haemorrhage following a therapeutic plasmapheresis session, depending on the type of session and the fibrinogen level at the end of the session. The hypothesis of our research is that the existence of a link between fibrinogen level and thrombin generation capacity, post therapeutic plasmapheresis, will enable us to better assess the risk of haemorrhage and to propose preventive measures.

Conditions

Hyperfibrinogenemia; Hemostatic Disorder

Keywords

Double Filtration Plasmapheresis; Single Plasma Exchange

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Patients benefitting from Single Plasma Exchange followed by Double Filtration Plasmapheresis

For the patients in this group, the first cycle (T1) will consist of Single Plasma Exchange and the second cycle (T2) of Double Filtration Plasmapheresis.

Group Type: ACTIVE_COMPARATOR

Single Plasma Exchange followed by Double Filtration Plasmapheresis

Intervention Type: PROCEDURE

Double Filtration Plasmapheresis followed by Single Plasma Exchange

Patients benefitting from Double Filtration Plasmapheresis followed by Single Plasma Exchange

For the patients in this group, the first cycle (T1) will consist of Double Filtration Plasmapheresis and the second cycle (T2) of Single Plasma Exchange.

Group Type: ACTIVE_COMPARATOR

Single Plasma Exchange followed by Double Filtration Plasmapheresis

Intervention Type: PROCEDURE

Double Filtration Plasmapheresis followed by Single Plasma Exchange

Interventions

Single Plasma Exchange followed by Double Filtration Plasmapheresis

Double Filtration Plasmapheresis followed by Single Plasma Exchange

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients without renal failure treated with chronic therapeutic plasmapheresis with a minimum treatment interval of 10 days and who can be treated with single plasma exchange (SPE) or double filtration plasmapheresis (DFPP) in accordance with the international recommendations.
• Therapeutic plasmapheresis with regional citrate anticoagulation.
• Patients over 18 years of age.
• Patient affiliated to or benefiting from a social security scheme.
• Free, informed and written consent, signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).

Exclusion Criteria

• Patients treated with oral anticoagulants or anti-platelet agents.
• Patients treated for hypercholesterolaemia or hypertriglyceridaemia; hyperviscosity, acquired haemophilia or nephrotic syndrome.
• Indication for substitution with fresh frozen plasma (FFP) for the treatment of the disease.
• Patient in an exclusion period determined by another study.
• Patient under court protection, guardianship or curatorship.
• Patient unable to give consent.
• Patient for whom it is impossible to give informed information.
• Pregnant or breast-feeding patients.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emilie PAMBRUN, Docteur

Role: PRINCIPAL_INVESTIGATOR

Nîmes University Hospital

Sylvie BOUVIER, Docteur

Role: PRINCIPAL_INVESTIGATOR

Nîmes University Hospital

Jean-Christophe GRIS, Professor

Role: PRINCIPAL_INVESTIGATOR

Nîmes University Hospital

Mathieu FORTIER

Role: PRINCIPAL_INVESTIGATOR

Nîmes University Hospital

Locations

CHU de Nîmes

Nîmes, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Olivier MORANNE, Professor

Role: CONTACT

Phone: +334.66.68.31.49

Email: olivier.moranne@chu-nimes.fr

Anissa MEGZARI

Role: CONTACT

Phone: +33466684236

Email: drc@chu-nimes.fr

Facility Contacts

Anne Clarisse SIMONET, PhD

Role: primary

Other Identifiers

NIMAO/2023-2/OM01

Identifier Type: -

Identifier Source: org_study_id